A45-12 Lung Tensioning Device for Severe, Heterogeneous Emphysema

Rationale Bronchoscopic lung volume reduction techniques have broadened the therapeutic arsenal for patients with severe emphysema and significant lung hyperinflation. However, the most established technique, endobronchial valves, only cover patients with complete fissures. For patients with collateral ventilation, some alternative approaches have been studied, like thermal vapor ablation or coils. Coils commercialization was ended prematurely by the last owner, despite a ∼50% responder rate. Although no studies have been specifically dedicated to this subpopulation, patients with the most severe hyperinflation (those whose residual volume (RV) exceeds 225% of pred) and with a heterogeneous distribution of emphysema appear to be more likely to benefit from coil treatment. Lung tensioning device (LTD, FreeFlowTM) is a modified coil which aims to improve the efficacy using a more complex shape and a proximal feature that anchors to the carina to increase tissue grasping and tensioning. We will present preliminary results from the first 14 patients treated in France with this new device. Methods Fourteen patients diagnosed with severe emphysema and significant dyspnea (mMRC2 or more) despite optimal treatment were selected according to strict clinical (FEV1 15-45% pred, RV > 225%) and radiological (heterogeneous distribution, defined as a 10% gradient with the adjacent lobe) criteria, based on the post-hoc analyses of clinical trials evaluating coils. Bilateral LTD implantation for 14 patients have started in December 2024 and are planned until February 2026 across two French centers. Demographic data, respiratory function parameters (FEV1, FVC, DLCO), quality of life (CAT, SGRQ), and exercise capacity (6-minute walking distance) are being collected before and 3, 6 and 12 months after the procedure. Safety and adverse events are also assessed. Results All patients selected had heterogeneous severe emphysema (median FEV1 32% pred) and significant hyperinflation (median RV 260% pred). Only 3 patients have undergone the 3 months follow-up at the date of abstract submission (13%, 36% and 20% FEV1 gain in these patients), but 3 months data will be available for all patients for ATS meeting. No deaths or severe adverse event were reported in the first 5 patients treated so far. Conclusion These preliminary outcomes will add more safety and efficacy data regarding LTD FreeflowTM treatment. Longer-term results in a larger cohort will be collected across 5 French centers.